Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft

Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft in Patients With Thoracic Aortic Pathologies

The purpose of this study is to evaluate the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy will be evaluated by the device-related adverse event rate of endovascular repair (via Relay Thoracic Stent-Graft) through 1-year. Safety will be evaluated by comparing major adverse events through 1-year in subjects treated with the Relay Thoracic Stent-Graft to those who underwent surgical repair. Long term follow-up is conducted through 5 years.

Inclusion Criteria:

• Subjects with diagnosed descending thoracic aortic aneurysms or penetrating atherosclerotic ulcers
• Subjects who are at least 18 years of age
• Subjects whose anatomy can accommodate the Relay device
• Subjects who consent to participate
• Subjects who agree to comply with follow-up schedule

Exclusion Criteria:

• Subjects with non-aneurysm lesions
• Subjects with less than 1 year life expectancy
• Subjects who are pregnant
• Subjects with medical conditions that would complicate the endovascular procedure or confound the results (e.g., Marfan's Syndrome, prior repair in the thoracic aorta, severe coronary artery disease, morbid obesity, etc.)
• Subjects participating in another investigational study